Outcomes of Operative Treatment of Unstable Ankle Fracture - Comparison Between Metallic and Biodegradable Implants
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- American Orthopaedic Foot and Ankle Society(AOFAS) score
研究概览
简要总结
The purposes of this study are to compare the outcomes of the biodegradable implants for the fixation of ankle fracture and those of metallic implants, and to assess the problems of the biodegradable implants. Null hypothesis is that the clinical outcomes of biodegradable plate and screws for ankle fracture are not different from those of metallic implants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •skeletally mature subjects (≥16 years old) with unilateral ankle fractures
排除标准
- •subjects less than 16 years old,
- •subjects not followed up at this hospital,
- •multiple injuries,
- •bilateral ankle fractures,
- •open fractures,
- •pathologic fractures,
- •concomitant tibial shaft fractures,
- •previous history of immobilization due to significant injury or a fracture of either ankle,
- •significant peripheral neuropathy,
- •soft tissue infection in the region on either injured ankle,
- •or inability to complete the study protocol
研究组 & 干预措施
metallic implant
fixation of the ankle fracture with metallic implants
干预措施: fixation of the ankle fracture (Solco ) (Device)
biodegradable implant
fixation of the ankle fracture with Freedom plate and screws
干预措施: fixation of the ankle fracture (Freedom) (Device)
结局指标
主要结局
American Orthopaedic Foot and Ankle Society(AOFAS) score
时间窗: 3 months, 6 months, 1 year
change from baseline(3 months after surgery)
次要结局
- Short Musculoskeletal Functional Assessment(SMFA) scale(3 months, 6 months, 1 year)
研究者
Jung Ho Noh
Orthopaedic Surgeon
National Police Hospital